摘要
目的:评价奥美拉唑肠溶胶囊的总体质量和现行质量标准的可行性。方法:依照现行法定标准对奥美拉唑肠溶胶囊进行检验,评价其质量状况。结果:本次评价性抽样共检验奥美拉唑肠溶胶囊51批,按现行法定标准检验,全部合格。结论:通过评价发现,奥美拉唑肠溶胶囊按现行标准检验总体质量良好。总结本次工作,提出药品质量评价侧重于释放度、有关物质,以及从源头规避风险的新思路。为提高检验效率,适应快检的要求对含量测定方法进行改进。
Objective: To evaluate the quality of Omeprazole enteric-coated capsules and the feasibility of the current quality standards. Methods: According to the current statutory standards, the quality of Omeprazole enteric-coated capsules was tested and evaluated. Results: Totally 51 batches of the capsules were tested in this evaluating inspection and all were qualifi ed according to the current statutory standards. Conclusion: The overall quality of the capsules tested was good according to the current inspection standards. In addition, drug quality evaluation should emphasize new approaches such as focusing on dissolution and related substance, avoidance of risks from the sources, etc. And the methods of content determination should be improved for the sake of rapid inspection so as to improve inspection effi ciency.
引文
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